Assessing Accuracy of the Freestyle Libre Pro Glucose Monitoring in Patients With Diabetes in a Critical Care Setting

NCT06800365 | Terminated FDA Device

• 1 other identifier: HSR #19-4700
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Currently, the standard of care for monitoring sugar levels in patients with diabetes in the intensive care unit is to use finger stick blood sugar monitoring. Finger stick blood sugar monitoring can be uncomfortable and time consuming. An alternate way to monitor sugar levels to use a sugar sensor, as part of the Abbott Freestyle Libre Flash glucose monitoring system, which has been approved for use outside of the hospital. The goal of the current research is to see whether using the sugar sensor gives accurate sugar readings in patients that are ill enough to be in the intensive care unit. If research confirms that the sensor is accurate, the investigators could potentially need to do fewer of those uncomfortable and time consuming blood sugar finger sticks. At this time, the Freestyle Libre Flash Glucose Monitoring system is not available for purchase without a specific prescription for each individual patient and also is not available for purchase for research use from the manufacturer, Abbott Laboratories. However, the Freestyle Libre Pro sensor is available and uses the same measurement technology to measure interstitial glucose as the Libre Flash Glucose Monitoring system sensor (but does not require sensor scanning to retain glucose data). As such, the Libre Pro sensor will be utilized for the current study. When a participant is enrolled in this study, they will have a Abbott Freestyle Libre Pro sensor applied to the back of their arm. They will continue to have finger stick glucoses checked as determined by their primary medical ICU team just as if they would if not enrolled in the study. After the participant leaves the hospital, the data from their finger stick glucoses and from the Libre will be compared by a statistical analysis to see how similar or different the glucose readings from the finger stick glucoses are as compared to the Libre sensor data.

Conditions

Diabetes Mellitus; Critical Illness; Continuous Glucose Monitoring

Keywords

Diabetes Mellitus; Critical Illness; Continuous glucose monitoring; Flash glucose monitoring

Outcome Measures

Primary Outcomes (6)

• Determination of numerical accuracy of Freestyle Libre Pro sensor glucose monitoring by calculation of the mean absolute relative difference

  Numerical accuracy will be defined by the mean absolute relative difference (MARD)

  From sensor placement to sensor removal (i.e 14 days or time of patient discharge, whichever comes first)

• Determination of numerical accuracy of Freestyle Libre Pro sensor glucose monitoring by use of the Bland-Altman method

  Numerical accuracy will be defined by the Bland-Altman method

  From sensor placement to sensor removal (i.e 14 days or time of patient discharge, whichever comes first)

• Determination of numerical accuracy of Freestyle Libre Pro sensor glucose monitoring by assessing adherence to International Organization for Standardization (ISO) criteria

  Numerical accuracy will be informed by whether the International Organization for Standardization (ISO) criteria are met

  From sensor placement to sensor removal (i.e 14 days or time of patient discharge, whichever comes first)

• Determination of numerical accuracy of Freestyle Libre Pro sensor glucose monitoring by assessing adherence to the Clinical and Laboratory Standards Institute Point of Care Testing (CLSI-POCT) criteria

  Numerical accuracy will be informed by whether the Clinical and Laboratory Standards Institute Point of Care Testing (CLSI-POCT) criteria are met

  From sensor placement to sensor removal (i.e 14 days or time of patient discharge, whichever comes first)

• Determination of clinical accuracy of Freestyle Libre Pro sensor glucose monitoring by Surveillance Error Grid (SEG) analyses

  Clinical accuracy will be defined by Surveillance Error Grid (SEG) analyses.

  From sensor placement to sensor removal (i.e 14 days or time of patient discharge, whichever comes first)

• Determination of clinical accuracy of Freestyle Libre Pro sensor glucose monitoring by Clarke Error Grid (CEG) analyses

  Clinical accuracy will be defined by Clarke Error Grid (CEG) analyses.

  From sensor placement to sensor removal (i.e 14 days or time of patient discharge, whichever comes first)

Secondary Outcomes (5)

• Hypoglycemic events

  From sensor placement to sensor removal (i.e 14 days or time of patient discharge, whichever comes first)

• Time in range

  From sensor placement to sensor removal (i.e 14 days or time of patient discharge, whichever comes first)

• Patient satisfaction: survey

  From sensor placement to sensor removal (i.e 14 days or time of patient discharge, whichever comes first)

• Nursing staff satisfaction and acceptability: survey

  Surveys to be administered to nursing staff at time of sensor removal from participant. Sensor removal takes place at time of patient discharge from hospital or when sensor has been in place for 14 days, whichever time point occurs first.

• Adverse event monitoring

  From sensor placement to sensor removal (i.e 14 days or time of patient discharge, whichever comes first)

Study Arms (1)

Sensor arm

EXPERIMENTAL

Sensor arm patients will have a glucose sensor applied to their physical arm.

Device: Sensor

Interventions

Sensor DEVICE

The FreeStyle Libre Pro sensor is a device whereby a sensor is inserted into subcutaneous tissue (upper arm) and measures the interstitial blood glucose which is then available for later download. It comes pre-calibrated meaning that no fingerstick glucose monitoring is required to improve accuracy of the sensor.

Sensor arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females age 18 and older. There is no upper age limit.
• English speakers.
• History of Type 1 or Type 2 diabetes (noted in electronic medical record or confirmed by patient or LAR).
• Admission to the medical intensive care unit with expected stay of at least 48 hours

You may not qualify if:

• New diagnosis or no known history of type 1 or type 2 diabetes.
• Patients with documentation stating desire not to participate in research.
• Prisoners.
• Documented allergy to adhesives or tape.

Sponsors & Collaborators

• Hennepin Healthcare Research Institute: lead
• University of Minnesota: collaborator

Study Sites (1)

Hennepin Healthcare

Minneapolis, Minnesota, 55415, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Critical Illness

Interventions

Calibration

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Weights and Measures; Investigative Techniques

Study Officials

• Laura Lafave, MD

  Hennepin County Medical Center, Minneapolis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking of whether participant is enrolled will take place. Data from sensor will be masked from the participant, care provider and investigator during sensor use.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Staff Endocrinologist

Model Details: The study will be a single arm, single center, prospective trial. Patients admitted to the medical ICU will be screened for eligibility criteria and enrollment will be offered if criteria are met.

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: January 30, 2025
• Study Start: April 6, 2021
• Primary Completion: September 21, 2021
• Study Completion: September 21, 2021
• Last Updated: January 30, 2025

Record last verified: 2025-01

Locations

US (1)